K920258 is an FDA 510(k) clearance for the QBC FIBRINOGEN. This device is classified as a System, Fibrinogen Determination (Class II - Special Controls, product code KQJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 26, 1992, 157 days after receiving the submission on January 21, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K920258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1992 |
| Decision Date | June 26, 1992 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | KQJ — System, Fibrinogen Determination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |